NAC excluded from dietary supplement definition in FDA’s latest draft guidance

22 Apr 2022 --- The US Food and Drug Administration (FDA) has revealed that N-acetyl-L-cysteine (NAC) is excluded from the dietary supplement definition under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The announcement comes alongside the availability of draft guidance on the FDA’s policy regarding products labeled as dietary supplements that contain NAC.

The news comes amid a flurry of activity in this space. Earlier this month, the FDA rejected industry petitions not to exclude the use of NAC in the definition of dietary supplements. The move has prompted industry to accuse the body of favoring pharma monopolies amid fears of future implications on dietary ingredients.

In a recent response to two citizen petitions, the FDA had determined that NAC is excluded from the dietary supplement definition under the FD&C Act because NAC was approved as a new drug before it was marketed as a dietary supplement or as a food.

When finalized, the draft guidance will explain the FDA’s intent to exercise enforcement discretion concerning the sale and distribution of certain NAC-containing products labeled as dietary supplements.

This enforcement discretion policy would apply to products that would be lawfully marketed as dietary supplements if NAC were not excluded from the definition of “dietary supplement” and are not, otherwise, in violation of the FD&C Act, states the FDA.

Industry reactions
In response to this week’s announcement, Daniel Fabricant, president and CEO of the Natural Products Association, says: “We’re glad we won this round, but we’re not glad we had to go to such great lengths to secure this for American consumers and a functioning regulatory regime. FDA could have and should have reached this decision years ago, but I credit NPA’s members for realizing what was at stake and being committed to this extraordinary effort.”

The FDA has determined that NAC is excluded from the dietary supplement definition under the FD&C Act.Meanwhile, a statement from the Council for Responsible Nutrition (CRN) president and CEO Steve Mister reads: “We thank FDA for realizing that retailers and marketers of NAC need clarity and certainty in the market and assurance from the agency that there are no known safety concerns with these products.”

“We hope the announcement by FDA provides retailers, payment platforms, and product marketers with the assurance they have been asking for – that they may continue to sell NAC- containing dietary supplements without the threat of FDA enforcement action. We are grateful for the agency’s statements that it is not aware of any safety-related concerns with NAC.”

Dietary supplement definitions
The FDA has not yet reached a final decision on one petitioner’s request to issue a regulation to permit the use of NAC in dietary supplements, and is considering initiating rulemaking to provide by regulation that NAC is not excluded from the definition of dietary supplement.

The FDA does not identify safety-related concerns as they continue to review the available data and information. They say they are “likely to propose a rule providing that NAC is not excluded from the definition of dietary supplement.”

While a full safety review of NAC remains ongoing, the FDA’s initial review has not revealed safety concerns with respect to the use of this ingredient in or as a dietary supplement.

Furthermore, NAC-containing products represented as dietary supplements have been sold in the US for over 30 years, and consumers continue to seek access to such products.

Accordingly, while the FDA continues its evaluation of the request to initiate rulemaking, the FDA issued this draft guidance to explain its policy regarding products labeled as dietary supplements that contain NAC.

Edited by Elizabeth Green

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